Intrauterine Device Insertion and Felt Pain

Not Applicable

Completed

• Conditions: Intrauterine Device Migration
• Interventions: Device: Intrauterine Device Insertion

• Registration Number: NCT05956184
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.

Detailed Description

The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.

Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.

In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.

Study Timeline

• Study Start: 2023-07-13
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• Volunteer to participate in the study
• Preferring an intrauterine device for the contraceptive method

Exclusion Criteria

• Patients with uterine leiomyoma
• Patients with endometriosis
• Patients with chronic pelvic pain
• Patients with familial mediterranean fever
• Patients who experienced complications during the procedure
• Patients who developed vasovagal reactions
• Patients who had previously used an IUD for any reason
• Patients with uterine anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convention Method Group	Intrauterine Device Insertion	Women who have an IUD inserted by conventional method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).
Direct Method Group	Intrauterine Device Insertion	Women who have an IUD inserted by direct method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	Thirty minutes	This is a numeric pain score evaluated as "painless" (score=0) and "worst pain" (score=10). Score \<3 mild pain, 3-6 mild-moderate pain, and \>6 moderate-to-severe pain.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Çankaya, Turkey